EDC for Clinical Trial Sponsors

EDC for clinical trial sponsors: selection criteria and fit for sponsor-led studies. EDC with eConsent, ePRO, and 21 CFR Part 11–aligned controls.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

EDC for Clinical Trial Sponsors

EDC for clinical trial sponsors must support sponsor-led build and operation: one platform for EDC, eConsent, and ePRO with 21 CFR Part 11–aligned controls and documentation for sponsor validation. This guide gives sponsors selection criteria, a checklist, common mistakes, and how Capture fits. Use it to build a shortlist or internal case for selecting software.

Selection criteria for sponsors

Sponsors need: one platform for consent and data capture (and ePRO if required); 21 CFR Part 11–aligned controls and HIPAA-aligned security; study builder or rapid deployment so sponsors can build or oversee build; documentation to support sponsor validation and UAT; and pricing and contract fit for sponsor-led studies. Avoid assuming only CRO-led implementation is available; many platforms support sponsor-led build.

Checklist for sponsor EDC selection

  • Integrated eConsent, ePRO, and EDC in one platform and one audit trail
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Study builder or rapid deployment; support for sponsor-led build and validation
  • Documentation and support for sponsor validation and UAT
  • Pricing and contract fit for sponsor-led studies
  • Export for analysis and regulatory use

Common mistakes for sponsors selecting EDC

  • Choosing software that requires CRO-led implementation when sponsor wants to build
  • Not securing documentation for sponsor validation and UAT
  • Underestimating implementation and change-control for sponsor-led studies
  • Not clarifying pricing and contract for sponsor-led use

Where Capture fits for sponsors

  • Single platform for EDC, eConsent, ePRO, and safety; study builder for sponsor-led build
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security; documentation for validation (Enterprise)
  • Book a demo to evaluate fit for sponsor-led studies

Related

EDC for CRO-independent trialsHow to choose an EDC systemFeatures

FAQ

Questions we hear a lot

What EDC fits clinical trial sponsors?
Look for one platform for EDC, eConsent, and ePRO with study builder and documentation for sponsor validation. Capture supports sponsor-led build and validation; book a demo to evaluate fit.
Is Capture 21 CFR Part 11–aligned?
Yes. Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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